Articularis Healthcare Group, Inc

Summary Statement of Deficiencies D0000 An announced onsite CLIA recertification survey was conducted on June 10. 2025, at the laboratory of Articularis Healthcare Group, Inc by the South Carolina Department of Public Health (SC DPH) Bureau of Nursing Homes and Medical Services. The laboratory was found to be out of compliance with Medicare condition 42 CFR Part 493, CLIA requirements for laboratories. The following is a list of Standard level deficiences cited as a result of the June 10, 2025 CLIA recertification survey: D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (b)(7) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on records review, American Proficiency Institute (API) Attestation Statement documents, and staff interview, the laboratory failed to ensure proficiency testing (PT) attestation statements had been signed by the laboratory director (LD) in 2 out of 27 PT events reviewed. Findings included: 1. Review of API PT attestation statements reveals the lack of LD's signature on the following events: a. API 2024 Hematology /Coagulation 3rd event, score 100% b. API 2025 Hematology/Coagulation 1st event, score 100% 2. Review of the API PT attestation statement document reveals the form is to be signed by all testing personnel and the laboratory director. 3. In an interview with the Technical Supervisor (TS) on July 10, 2025 at 1:50pm in the laboratory, the findings were confirmed. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on records review, lack of documentation, and staff interview, the laboratory failed to document twice annual function checks of the Laboratory Information System (LIS) for results accuracy in 3 out of 3 years reviewed. Findings included: 1. Review of laboratory quality assessment (QA) manual reveals the QA monitors for the laboratory. 2. Twice annual quality assessment of the LIS for functional checks and testing accuracy is not included in the laboratory's QA plan. 3. Review of laboratory records reals a lack of documentation for twice annually quality assessment of the LIS. 4. In an interview with the TS on July 10, 2025, at 1:50pm in the laboratory, the findings were confirmed. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on direct observation and staff interview, the laboratory failed to ensure that expired testing equipment were not available for use in 4 out of 4 uninterupted power supply units. Findings included: 1. During a tour of the laboratory on July 10, 2025, at 1:50pm, surveyor observed uninterrupted power suppliers (UPS) in use as follows: a. Abbott Alinity c #1analyzer utilizing a POWERVAR UPS with manufacturer recommended battery replacement date of August 2024. b. Abbott Alinity c #2 analyzer utilizing a POWERVAR UPS with manufacturer recommended battery replacement date of March 2023. c. Sysmex XN2000 #1 analyzer utilizing a POWERVAR UPS with manufacturer recommended battery replacement date of April 2024. d. Sysmex XN2000 #2 analyzer utilizing a POWERVAR UPS with manufacturer recommended battery replacement date of May 2024. 2. In a interview with the Technical Supervisor (TS) on July 10, 2025, at 1:50pm in the laboratory, the findings were confirmed. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on records review and staff interview, the laboratory failed to document the manufacturer's instructions for routine centrifuge maintenance and care for 2 out of 2 centrifuges investigated. Findings included: 1. Review of manufacturer's instruction manual for the LW Scientific ComboXL centrifuge reveals the statement, "Keep the rotor inserts clean". 2. Review of the manufacturer' instruction manual for the LW Scientific MX5 centrifuge reveals the statement, "Keep the rotor shields clean". 3. Review of laboratory maintenance logs reveals a lack of documentation for centrifuge -- 2 of 3 -- maintenance and care. 4. In an interview with Technical Supervisor (TS) on July 10, 2025, at 1:50pm in the laboratory, the findings were confirmed. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on records review, personnel documentation, and staff interview, the TS failed to ensure evaluation of the competency of all testing personnel at the frequency determined from the laboratory's competency policy and procedure for 1 out of 3 Testing Personnel (TP) reviewed. Findings included: 1. Review of the laboratory procedure manual reveals the "Competency Testing Procedure" which indicates competency assessment are to occur as follows: a. Initial Competency b. 6 Months Competency c. Annual Competency 2. Review of personnel records reveals a lack of documentation for 6 months competency evaluation for TP3. 3. In an interview with the TS on July 10, 2025, at 1:50pm in the laboratory, the findings were confirmed. -- 3 of 3 --

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: During an onsite recertification survey on 6/22/21, based on observing documentation and personnel interview, the laboratory failed to sign the attestation statement of the proficiency testing packet Findings include 1.Observation of the proficiency testing packet for Chemitry showed that attestation statements for events A,B and C for 2018, 2019, and 2020 weren't signed by lab director. 2.Observation of the proficiency testing packet for Hematology showed that attestation statements for events A,B and C for 2018, 2019, and 2020 were not signed by lab director. 3. During an onsite interview with staff at 12:22pm, staff stated that the lab director had failed to sign the attestation statements. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: During a PT desk review performed on 2/27/2018, based on review of CASPER reports 153D, 155D and graded reports from American Proficiency Institute (API), the laboratory failed to successfully participate in proficiency testing for the subspecialty of endocrinology, the analyte thyroid stimulating hormone (TSH) for two consecutive events reviewed (2017, Events 1 and 2). See D2099 and D2107. D2099 ENDOCRINOLOGY CFR(s): 493.843(b) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: During a PT desk review performed on 2/27/2018, based on review of CASPER report 155D and graded reports from API, the laboratory failed to attain an overall test event score 80 percent for the subspecialty of endocrinology, for two consecutive events reviewed (2017, Events 1 and 2). Findings include: 1. Review of the CASPER report 155D revealed the following event scores for endocrinology: a. 2017, Event 1: 50% b. 2017, Event 2: 50% 2. The scores were confirmed upon review of the graded PT report from API. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: During a PT desk review performed on 2/27/2018, based on review of CASPER report 155D and graded reports from API, the laboratory failed to achieve satisfactory performance for the regulated analyte TSH in two consecutive testing events reviewed (2017, Events 1 and 2). Findings include: 1. Review of the CASPER report 155D revealed the following event scores for TSH: a. 2017, Event 1: 0% b. 2017, Event 2: 0% 2. The scores were confirmed upon review of the graded PT report from API. -- 2 of 2 --